“Diabetes Interactive Diary” (DID): a new telemedicine system enabling flexible diet and insulin therapy while improving the quality of life: an open label, international, multicentre, randomized study

  1. Maria CE Rossi, MSC Pharm Chem (mrossi{at}negrisud.it)1,
  2. Antonio Nicolucci, MD1,
  3. Paolo Di Bartolo, MD2,
  4. Daniela Bruttomesso, MD3,
  5. Angela Girelli, MD4,
  6. Francisco J Ampudia, MD5,
  7. David Kerr, MD6,
  8. Antonio Ceriello, MD7,
  9. Carmen De La Questa Mayor, MD8,
  10. Fabio Pellegrini, MSC Stat1,
  11. David Horwitz, MD9 and
  12. Giacomo Vespasiani, MD10
  1. 1 Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, S. Maria Imbaro (CH), Italy
  2. 2 Diabetes Unit, Presidio Ospedaliero, Ravenna, Italy
  3. 3 Clinical and Experimental Medicine, Policlinico Universitario, Padova, Italy
  4. 4 Diabetes Unit, Spedali Civili, Brescia, Italy
  5. 5 Unit of Endocrinology, Hospital Clínico Universitario, Valencia, Spain
  6. 6 Centre of Postgraduate Medical Research and Education, Bournemouth University, Bournemouth, UK
  7. 7 Warwick Medical School, University of Warwick, Coventry, UK
  8. 8 Unit of Endocrinology, Hospital Universitario Virgen Macarena, Sevilla, Spain
  9. 9 Medical & Clinical Affairs LifeScan Inc, Milpitas, California, USA
  10. 10 Diabetes Unit, Madonna del Soccorso Hospital, S. Benedetto del Tronto (AP), Italy

    Abstract

    Objective: A widespread use of carbohydrate (CHO) counting is limited by its complex education. This study compares a Diabetes Interactive Diary (DID) with standard CHO counting in terms of metabolic and weight control, time required for education, quality of life, and treatment satisfaction.

    Research design and methods: Adults with T1DM were randomized to DID (Group A, N=67) or standard education (Group B, N=63), and followed-up for 6 months. A subgroup also completed SF-36 and WHO-DTSQ questionnaires at each visit.

    Results: Of 130 patients (age 35.7±9.4 years; diabetes duration 16.5±10.5 years), 11 dropped out. Time for education was of 6 hours (range 2-15) in group A and 12 hours (2.5-25) in group B (p=0.07). HbA1c reduction was similar in both groups (Group A: from 8.2±0.8 to 7.8±0.8; Group B: from 8.4±0.7 to 7.9±1.1; p=0.68). Non-significant differences in favor of Group A were documented for FBG and body weight. No severe hypoglycemic episode occurred.

    WHO-DTSQ scores increased significantly more in group A (from 26.7±4.4 to 30.3±4.5) than in group B (from 27.5±4.8 to 28.6±5.1) (p=0.04). Role physical, general health, vitality, and role emotional SF-36 scores improved significantly more in group A than in group B.

    Conclusions: DID is at least as effective as traditional CHO counting education, allowing dietary freedom to a larger proportion of T1DM patients. DID is safe, requires less time for education, and is associated with lower weight gain. DID significantly improved treatment satisfaction and several quality of life dimensions.

    Footnotes

      • Received July 21, 2009.
      • Accepted September 16, 2009.

    This Article

    1. Diabetes Care
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